Oral dispersible films have been introduced in the market as an alternative to conventional oral dosage forms to enhance patient compliance. For example, mucoadhesive film formulations have been described that improve absorption of pharmaceutical agents through the mucosal tissue to bypass barriers in the gastrointestinal tract. Oral dispersible films also can overcome the swallowing problems associated with the capsules or tablets. Many of the oral dispersible films that have previously been disclosed are designed for delivering a particular pharmaceutical agent. It is desirable to develop an oral dispersible film with a matrix flexible enough to incorporate a variety of agents, e.g. pharmaceutical agents, nutraceutical agents, dietary supplements, or cosmetic agents.
Oral dispersible films that are currently available can become sticky over time when exposed to ordinary environment conditions, even at minimal humidity, leading to low stability and undesirable texture and appearance. Typically oral dispersible films employ hydrophilic polymers as film forming agents, which can exacerbate stability issues due to their water-soluble nature. Even formulations proposed to overcome these issues have been based on hydrophilic polymers, as described in US 2004/0247648 and US 2011/0293673 (disclosing modified starch and a mixture of polyvinylpyrrolidone, and hydroxypropylcellulose, respectively).
Current oral dispersible films typically are able to carry and deliver only relatively low percentage by weight of an active agent. High loading of active agent in the film tends to interfere with film formation, film stability and desirable film properties.
There is a need for development of an oral dispersible film dosage form having flexibility for use with various agents, particularly at high active agent content, and having increased chemical stability and resistance to room and environmental conditions without compromising rapid disintegration time, texture and appearance.